MAUDE manufacturer profile
ABBOTT MEDICAL · OAE
MAUDE profile for Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Key facts
| Manufacturer | ABBOTT MEDICAL |
|---|---|
| Manufacturer group | ABBOTT MEDICAL |
| Product code | OAE |
| Product code name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Cardiac Perforation, Optical Problem, Fracture, Communication or Transmission Problem, Heart Block, Patient Device Interaction Problem Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1